The Lundquist Institute (TLI) and its start-up company Vitalex Biosciences (Vitalex) are pleased to announce that the second-generation fungal vaccine candidate known as VXV‑01, which was developed using a proprietary TLI vaccine technology platform, is poised to move forward in development up to and including Phase 1 clinical evaluation — enabled by a major contract awarded to a collaboration consortium of Vitalex and Appili Therapeutics (TSX: APLI; OTCPink: APLIF). The contract from the National Institute of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) is valued at up to US $40 million. It will support the development of VXV-01 from manufacturing and non-clinical studies through two Phase 1 clinical trials. This contract represents a significant milestone for The Lundquist Institute’s vaccine research program.
Key Highlights
Vitalex has an exclusive option to license VXV-01 from TLI for commercial development.
The contract, awarded by NIH/NIAID, provides up to US $40 million of non-dilutive funding to Vitalex and its collaborator Appili and for the comprehensive development of VXV-01.
VXV-01 is built on the TLI (Therapeutic & Laboratory Immunology) technology platform developed at TLI, a second-generation approach containing two antigens designed to target invasive Candida infections with broader-spectrum cross-kingdom protection potential against Gram negative healthcare-associated infections.
With this funding, the program is positioned to begin manufacturing and other preparations necessary to initiate two Phase 1 clinical trials, which, when they occur, will mark a transition from preclinical research into the first stage of human testing.
Advancing VXV-01 into development up to and including Phase 1 trials brings it one step closer to delivering a novel prophylactic solution for serious fungal infections, a major unmet need in infectious disease.
“Securing this contract is a pivotal moment for our team,” said Ashraf Ibrahim, PhD, Principal Investigator and VXV-01 program lead at TLI and CEO of Vitalex. “By putting VXV-01 into development through human trials, we are significantly increasing our chances of making this vaccine a reality. It is the culmination of years of work on our TLI technology platform and reflects our commitment to tackling high-impact infectious disease challenges.”
About VXV-01
VXV-01 is a dual-antigen fungal vaccine candidate designed to elicit robust immunity against key opportunistic and hospital-associated Candida and Gram-negative bacterial pathogens. Built at TLI and further developed by Vitalex, VXV-01 is engineered for strong immunogenicity, manufacturability and scalability. The move into Phase 1 human trials marks the transition from lab and animal model proof-of-concept to human safety and immunogenicity studies.
About TLI
Founded in 1952, TLI is a leading nonprofit research organization at the heart of Los Angeles County’s life sciences ecosystem. Guided by a “bedside to bench to bedside” approach, TLI bridges cutting-edge discovery and real-world health impact. Through strong community partnerships, TLI conducts research that addresses pressing health needs, advances technology transfer and commercialization, and accelerates the path from breakthrough science to practical solutions that improve lives locally and globally. For more information, visit lundquist.org.
About Vitalex
Vitalex is a start-up company created to further the development of technologies discovered in the laboratory of its founder, Dr. Ashraf Ibrahim, a senior investigator at TLI and a Professor at the David Geffen School of Medicine at UCLA. Vitalex has obtained >$10 million in non-dilutive funding from the NIAID to further the development of a dual antigen vaccine that targets hospital-acquired infections caused by multidrug resistant Candida albicans, Candida auris, and Gram-negative bacteria including those caused by Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae. Vitalex is also developing a humanized monoclonal antibody against mucormycosis, a lethal and rare fungal infection. For more information, visit www.vitalexbiosciences.com.
About Appili Therapeutics
Appili Therapeutics is a biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA-approved ready-made suspension of metronidazole for the treatment of antimicrobial resistant infections, a vaccine candidate to prevent tularemia, a serious biological weapon threat, and a topical antiparasitic for the treatment of cutaneous leishmaniasis, a disfiguring disease. Led by a proven management team, Appili is at the center of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding the development of VXV-01, including its advancement into clinical trials, the benefits of the TLI technology platform, and the potential for VXV-01 to become a realized vaccine. Actual results may differ materially from those projected due to risks and uncertainties, including regulatory approval, clinical trial outcomes, manufacturing challenges, and funding uncertainties.
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